1. Field of the Invention
The present invention relates to a process to promote the viability, sustainability and growth of living cells, and in particular, for the treatment of an area of the body affected by disease or injury, and apparatus for effecting the process.
2. Brief Description of the Prior Art
Wounds and tissue injuries constitute a very large grouping of medical conditions including ischemic ulcers, traumatic injuries thermal injuries, and mechanical musculoskeletal injuries (including but not limited to skin, muscle, cartilage, ligament, and tendon injuries).
A wide variety of skin disorders can also be included, such as psoriasis, atopic dermatitis, skin infections including bacterial, fungal, and viral diseases, and post viral processes such as shingles.
Additionally, a wide variety of disease processes and injuries affect visceral organs and other internal structures throughout the body.
While it is difficult to quantify all the skin diseases, ulcers, burns, sprains, and other injuries that occur in the population, they are believed to occur in many millions of patients in the United States alone. For example, in a Canadian study, 1.8% of the population was determined to have open or healed ulcers of the lower extremity. Extrapolation of this data results in an estimated 5.3 million such patients in United States alone, which is likely conservative given the considerably higher rate of diabetes and peripheral vascular disease in the United States. Similarly, in a literature review from 1987, over one million people per year sought medical attention each year in the United States for ankle sprains alone. Low back pain is another perhaps more far-reaching example given the elusive nature of current treatment strategies to resolve this chronic condition. Thus, this would presumably be an exceedingly conservative estimate of current conditions, given the growth of exercise in the youth and adult population as well as the preponderance of patients who do not seek physician attention for their less significant injuries. Adding the number of skin diseases, burn injuries, traumatic wounds, and other wounds and tissue injuries yields estimates in the tens of millions of wound and tissue injury patients in the United States alone each year.
The healing of ischemic and other wounds and tissue injuries is promoted by the delivery of adequate oxygenation to the affected areas.
A variety of techniques are used by doctors and physical therapists to deliver oxygen and thus promote such healing. These include revascularization of areas with interrupted blood flow (via surgical bypass or endovascular therapy), drug therapy, and local warming (via direct heat application or ultrasound) to increase local perfusion and improve oxygen delivery.
Hyperbaric therapy has also been used for direct delivery of oxygen to tissue sites via a pressurized, oxygenated environment to treat wounds.
Perfluorochemical (PFC) liquids have been used to deliver oxygen systemically via the lungs and as an artificial blood substitute. In addition, the anti-inflammatory nature of PFC liquids and vapors when used in cell and in vivo conditions has been demonstrated. A fluorocarbon liquid has been used in a bath environment to partially treat foot ulcers. T. Iwai et al, “A new treatment for ischemic ulcers: foot bath therapy using high oxygen soluble fluid,” J. Cardiovasc. Surg. (Torino) 1989 May-June; 30(3): 490-3.
There is a continuing need for methods for promoting the healing of areas of the body affected by wounds or disease, and in particular for a method for treating ischemic ulcers, traumatic injuries, thermal injuries, and mechanical musculoskeletal injuries.